The FDA is alerting the public that a nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy. Also, a nipple aspirate test should not be used alone to screen for or diagnose breast cancer.
A nipple aspirate device is a pump used to collect fluid from a woman’s breast. The test can determine whether the breast fluid contains any abnormal cells.
Some manufacturers claim that a nipple aspirate test is an alternative to biopsy or mammography, and that it can detect precancerous abnormalities and diagnose breast cancer before mammography with a small cell sample.
If women follow these misleading claims and do not get mammograms and/or other necessary imaging tests or biopsies, it can lead to serious consequences.
Adverse consequences may include false negative or false positive test results. False negative results may lead to delayed diagnosis or treatment, which increases the risk of serious illness or death. False positive results may lead to unnecessary anxiety, testing, and treatment.
The FDA emphasizes to not use a nipple aspirate test as a substitute for mammography or by itself for breast cancer screening or diagnosis.
For more information call (888) 463-6332 or visit the FDA MedWatch page.